The US Food and Drug Administration (FDA) has issued 510k clearance for US Medical Innovations’s Canady Helios Cold Plasma (CHCP) Ablation System, a new technology designed for the ablation of soft tissue at the time of surgery.
The system comprises the Canady Helios Cold Plasma XL-1000 CP Smart Electrosurgical Generator, Canady Helios Cold Plasma Ablators, a foot pedal, and a trolley cart.
It uses plasma to create a plasma jet that operates at a non-thermal temperature range of 24°C to 30°C.
The plasma jet, which is applied intra-operatively for five to seven minutes, targets the soft tissue surgical margin following the removal of a solid tumour.
Its unique Plasma Treated Electromagnetic Field permeates cellular membranes, inducing apoptosis while preserving the surrounding healthy tissue.
US Medical Innovations chief technology officer Taisen Zhuang said: “This milestone allows us to integrate our revolutionary technology with our vision of creating the world's first AI-driven cold plasma robotic delivery system.
“We believe this powerful combination represents the most promising path forward in surgical oncology, offering unprecedented precision and efficacy.”
The Jerome Canady Research Institute for Advanced Biological and Technological Sciences previously conducted a Phase I clinical trial, showcasing the safety and efficacy of this technology.
The CHCP system demonstrated ‘exceptional safety and efficacy profiles’ with up to an 80% non-local recurrence rate and an overall survival rate of up to 86%.
JCRI research vice-president Saravana Murthy said: “In addition to the advantages associated with surgical margin ablation, our preclinical investigations, supplemented by a multitude of published studies, indicate that CHCP-treated cancerous cells elicit the release of highly specific and immuno-stable antigens, potentially inducing a systemic response conducive to targeted immunotherapeutic applications or as complementary modalities alongside established standards of care.”
US Medical Innovations is planning to distribute the plasma system in hospitals late this year.
